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A Diagnostic Test Kit For Uric Acid

Abstract: Title: A diagnostic test kit for Uric Acid A diagnostic test kit for Uric Acid consist of a kit of reagent of Buffer, Uricase and peroxidase operates through a process includes transferring the reagent at room temperature in to the blood serum/ plasma sample test tubes; incubating the reaction mixture; determining the absorbance of said test sample on photometer; and finally calculating the absorbance using factor to determine Uric Acid in vitro from the test serum / plasma sample effectively.

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Patent Information

Application #
Filing Date
02 February 2024
Publication Number
32/2025
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

LORD'S MARK INDUSTRIES LIMITED
B-101, RIDHI SIDHI COMPLEX M G ROAD, BORIVALI (EAST), MUMBAI - 400066, MAHARASHTRA, INDIA

Inventors

1. LORD'S MARK INDUSTRIES LIMITED
B-101, RIDHI SIDHI COMPLEX M G ROAD, BORIVALI (EAST), MUMBAI - 400066, MAHARASHTRA, INDIA

Specification

Description:Title of the Invention
“A Diagnostic Test Kit for Uric Acid”
Field of the Invention
The present disclosure relates generally to field of medical devices. More specifically the present invention relates to diagnostic test kit works on photometric method to determine Uric Acid from blood serum / plasma in vitro for laboratories and medical professionals.
Background of Invention
Uric acid is the end product of purine metabolism in man. The findings of human pathological levels of uric acid in serum and urine have in most patients serious clinical implications. This paper summarizes aspects of uric acid examination in clinical biochemistry laboratory. The clinical consequences of pathological levels of uric acid are shown. Uric acid is a useful diagnostic tool as screening for most of purine metabolic disorders. The importance of uric acid measurement in plasma and urine with respect of metabolic disorders is highlighted. Not only gout and renal stones are indications to send blood to the laboratory for uric acid examination. Also familial nephritis, neurological abnormalities with mental retardation are reasons to know uric acid levels in blood and urine. The results underline the importance of urinary uric acid investigation, which is often quite overlooked, and is helpful in differential diagnosis of gout. A uric acid blood test may be used to: Help diagnose gout, usually when done with a synovial fluid analysis. Monitor uric acid levels in people who are having cancer chemotherapy or certain other cancer treatments. When treatment kills cancer cells quickly, they release large amounts of purines into the blood. This can lead to serious problems from high uric acid levels. Testing helps catch an increase in uric acid so it can be treated early. A uric acid urine test may be used to: Help find out whether high levels of uric acid are causing kidney stones Monitor the risk of developing kidney stones in people who have gout. A uric acid test may be done as a blood test or a urine test.

For a blood test, a health care professional will take a blood sample from a vein in your arm, using a small needle. After the needle is inserted, a small amount of blood will be collected into a test tube or vial. You may feel a little sting when the needle goes in or out. This usually takes less than five minutes. For a uric acid urine test, you'll need to collect all your urine during a 24-hour period. This is called a 24-hour urine sample test. You will be given a special container to collect your urine and instructions on how to collect and store your samples. Your provider will tell you what time to start. The test generally includes the following steps: To begin, urinate in the toilet as usual. Do not collect this urine. Write down the time you urinated. For the next 24 hours, collect all your urine in the container.
During the collection period, store the urine container in a refrigerator or in a cooler with ice. 24 hours after starting the test, try to urinate if you can. This is the last urine collection for the test. Return the container with your urine to your provider's office or the laboratory as instructed.

Therefore, there is a need for a device that overcomes at least the above mentioned problems. There is a need for a rapid, precise, and cost-effective diagnostic kit and method for the measurement of Uric Acid.
The present disclosure relates generally to field of medical devices. More specifically the present invention relates to diagnostic test kit works on photometric method to estimate Uric Acid from serum / plasma, in vitro for laboratories and medical professionals.
Object of the Invention
The primary object of the invention is to develop a diagnostic test kit to estimate Uric Acid from blood serum / plasma useful effectively.
The secondary objective of the invention is that the diagnostic test kit for Uric Acid utilizes photometric method herein the kit configured with suitable reagents like Buffer, Uricase, Peroxidase and Uric Acid as standard taken in effective concentration of blood serum /plasma.
Another objective of the invention is that the prepared blood serum/plasma samples with reagents estimated for absorbance in photometer at desired wavelength and room temperature.
Further objective of the invention is that Uric Acid is determined through calculation by the absorbance of sample and standard.
Summary of the Invention

The present disclosure relates a diagnostic kit specifically to determine Uric Acid concentration in the blood serum/plasma wherein the desired size kit is developed, essentially consist of reagents for reaction with blood serum/plasma samples, detected on photometer at desired wavelength to measure the absorbance and finally calculated to determine Uric Acid concentration.
A diagnostic test kit for Uric Acid comprising a test kit characterized in that 50 ml and 100 ml size kit of one compartment cell reagents preferably consist of Buffer, Uricase and Peroxidase with Uric Acid as standard estimate Uric Acid in vitro from blood serum / plasma sample effectively, wherein reagent cell composed of of 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase, taken with blood serum/ plasma sample from 0.020 ml to 0.025 ml into two clean test tube for test sample and blank sample and Uric Acid 6 mg/dl sample as standard in third test tube; pipette out the reagent from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC) and , uniformly mixed with test sample, blank sample and standard; incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample blank sample and standard Uric Acid sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Uric Acid from the test serum / plasma sample effectively.

One of the preferred embodiments of the present invention is the unique design of the kit prefilled with the preferred reagent like Buffer, Uricase and Peroxidase reacts with serum/ plasma Uric Acid evaluated through the absorbance on photometer.

One of the preferred embodiments of the present invention is that to determine Uric Acid from the varied concentration more preferably making the test sample, blank sample and standard Uric Acid sample to infer the clinical findings effectively.

One of the preferred embodiments of Uric Acid is estimated in vitro through all in one reagent kit.

Brief Description of Drawings

The following thorough explanation of the various aspects of the invention, taken in conjunction with the corresponding drawing that represents various aspects and other features of the disclosure invention.

Figure 1: Flow chart of method to operate estimation of Uric Acid

Detailed Description of the Invention

The following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration through explanation and figures for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the ingredients described without departing from the scope of the invention.
The use of “including”, “comprising” or “having” variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.
The terms used in the invention
mmol: milimole
mmol/l: millimole per liter
Uric acid is the end product of purine metabolism in man. The findings of human pathological levels of uric acid in serum and urine have in most patients serious clinical implications. This paper summarizes aspects of uric acid examination in clinical biochemistry laboratory. The clinical consequences of pathological levels of uric acid are shown. Uric acid is a useful diagnostic tool as screening for most of purine metabolic disorders. The importance of uric acid measurement in plasma and urine with respect of metabolic disorders is highlighted. Not only gout and renal stones are indications to send blood to the laboratory for uric acid examination. Also familial nephritis, neurological abnormalities with mental retardation are reasons to know uric acid levels in blood and urine. The results underline the importance of urinary uric acid investigation, which is often quite overlooked, and is helpful in differential diagnosis of gout.
A diagnostic test kit for Uric Acid comprising a test kit characterized in that 50 ml and 100 ml size kit of one compartment cell reagents preferably consist of Buffer, Uricase and Peroxidase with Uric Acid as standard estimate Uric Acid in vitro from blood serum / plasma sample effectively, wherein reagent cell composed of of 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase, taken with blood serum/ plasma sample from 0.020 ml to 0.025 ml into two clean test tube for test sample and blank sample and Uric Acid 6 mg/dl sample as standard in third test tube; pipette out the reagent from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC) and , uniformly mixed with test sample, blank sample and standard; incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample blank sample and standard Uric Acid sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Uric Acid from the test serum / plasma sample effectively.
The present disclosure relates a diagnostic kit specifically to determine Uric Acid concentration in the blood serum/plasma wherein the desired size kit is developed, essentially consists of reagents for reaction with blood serum/plasma samples, detected on photometer at desired wavelength to measure the absorbance and finally calculated the Uric Acid concentration.
Preferred embodiments of Uric Acid kit
i) Diagnostic Kit: The Uric Acid kit comprises of 50 ml and 100 ml size wherein reagent cell prefilled for the determination of Uric Acid, herein the key reagent t like Buffer, Uricase and Peroxidase reacts with serum/ plasma Uric Acid used in different concentration, estimates serum / plasma Uric Acid through the absorbance using photometer of desired wavelength.
ii) Reagents: Blood serum /plasma, Buffer, Uricase and Peroxidase.
iii) Apparatus / Instrument: Test tubes, Photometer, Incubator etc.
Table no. 01: Preferred embodiments and parameters of the kit with concentrations

Particulars Name of ingredient with concentration
Serum/ plasma sample 0.020 ml to 0.025 ml
Reagent 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase
Shelf Life 24 months
Kit Size 50 ml and 100 ml
Wavelength 510 nm
Temperature 37oC
Time of Estimation 30 to 90 seconds

Table no. 02: Method to operate Uric Acid kit

Particulars Blank Standard Sample
Reagent 1.0 ml 1.0 ml 1.0 ml
Standard -- 0.020 ml --
Serum/plasma test sample -- -- 0.020 to 0.025 ml

General Method to operate the device

Taking the 0.020 to 0.025 ml blood serum/ plasma sample as test sample, reagent as blank sample and Uric Acid as standard separately in clean test tubes;
pipette out the reagent 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample, blank sample and standard Uric Acid sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Uric Acid from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 6 mg/dl
(Table No. 1, 2 and Figure No. 1)
Example 1
Taking the 0.020 ml blood serum/ plasma sample as test sample, reagent as blank sample and Uric Acid as standard separately in clean test tubes;
pipette out the reagent 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample, blank sample and standard Uric Acid sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Uric Acid from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 6 mg/dl
Example 2
Taking the 0.025 ml blood serum/ plasma sample as test sample, reagent as blank sample and Uric Acid as standard separately in clean test tubes;
pipette out the reagent 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample, blank sample and standard Uric Acid sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Uric Acid from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 6 mg/dl
Scope of the Invention

A diagnostic test kit for Uric Acid principally design to develop a simple method to analyse the Uric Acid level using photometric method having size of 50 ml and 100 ml size kit of reagent preferably consist of effective concentration of 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of peroxidase, taken with blood serum/ plasma sample from 0.020 ml to 0.025 ml as test sample and blank sample and Uric Acid 6 mg/dl sample as standard respectively determines Uric Acid in vitro from blood serum / plasma sample effectively, could be potential diagnostic and economical method, compare to expensive conventional methods in future.

It is to be understood that the present invention is not limited to the embodiments described above, it should be clear that various modifications and alterations can be made along with various features of one embodiment included in other embodiments, within the scope of the present invention.
, Claims:We claim,
1- A diagnostic test kit for Uric Acid comprising a test kit characterized in that 50 ml and 100 ml size kit of reagent preferably consist of effective concentration of 100 mmol/l of Buffer, 200 u/l of Uricase and 0.6 u/l of Peroxidase estimates Uric Acid in vitro from blood serum / plasma sample taken from 0.020 to 0.025 ml as test sample and Uric Acid ( 6 mg/dl) as standard, using photometer effectively.

2- The diagnostic test kit for Uric Acid as claimed in claim 1, operates through in vitro diagnostic method to determine Uric Acid comprises the following steps:
taking the 0.020 to 0.025 ml blood serum/ plasma sample as test sample, reagent as blank sample and Uric Acid as standard separately in clean test tubes;
pipette out the reagent Buffer, Uricase and peroxidase from the kit separately;
transferring said reagent into the test tubes respectively at room temperature (37oC);
incubating the reaction mixture for 5 minutes;
determining the absorbance of said test sample, blank sample and standard Uric Acid sample on photometer at a wavelength of 510 nm for 30-90 seconds; and
calculating the absorbance to estimate Uric Acid from the test serum / plasma sample effectively.

Documents

Application Documents

# Name Date
1 202421007351-STATEMENT OF UNDERTAKING (FORM 3) [02-02-2024(online)].pdf 2024-02-02
2 202421007351-FORM 1 [02-02-2024(online)].pdf 2024-02-02
3 202421007351-DRAWINGS [02-02-2024(online)].pdf 2024-02-02
4 202421007351-DECLARATION OF INVENTORSHIP (FORM 5) [02-02-2024(online)].pdf 2024-02-02
5 202421007351-COMPLETE SPECIFICATION [02-02-2024(online)].pdf 2024-02-02